FEATURED EDITORIAL
A lower-court ruling does not make a victory. But it adds a little sanity to this melodrama. On August 7, a U.S. District Judge did something that has been surprisingly rare in the long-running WuXi AppTec/BIOSECURE Act saga: He looked at the U.S. government's case for labeling WuXi a “Chinese military company” and decided the government had not shown enough evidence. Analysis from Chief Editor Louis Garguilo.
- In Bioprocessing, Trusted Data Is A Process Variable
- Combination Cell Therapy's Clinical Success Hinges On Manufacturability
- Are Biopharma Companies Outsourcing Their Ability To Think?
- Global Ties, Good Fortune Bind Biotech And CDMO
- June 2026 — CDMO Opportunities And Threats Report
- The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
- Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
GUEST COLUMNISTS
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Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.
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June 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.
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Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.
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Reshoring Pressure Meets Manufacturing Reality
U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.
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CDMO Live Europe 2026: Partnerships For An Uncertain World
112 pages of executive insight from CDMO Live Europe 2026: tariffs, geopolitics, supply resilience, AI in manufacturing, and why strategic partnerships remain aspirational for most.
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Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
Senior pharma leaders from Pfizer, Bayer, BioNTech and others debunk dual sourcing myths and reveal what separates strategic CDMO partnerships from transactional ones.
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Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.
PHARMA OUTSOURCING WHITE PAPERS
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Overcoming Challenges To High-Concentration Formulation Development
Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.
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Optimizing Safety Measures For rAAV Therapies
Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.
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Random And Semi-Targeted Integration In Cell Line Development
While semi-targeted approaches may offer precision, uncover how they may fall short in overall efficiency and productivity, especially in late-stage manufacturing.
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Facilitate Handling Of Bulk Powders With Dry Granulation
Handling bulk powders in manufacturing presents serious challenges—from unpredictable caking to safety risks—that can disrupt workflows. Discover solutions to streamline operations and protect your team.
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Empowering Antibody Discovery With ProSpeed™
Integrating linear expression technology into single B cell workflows accelerates antibody discovery, enabling early functional screening, improved sensitivity, and cost-effective identification of diverse therapeutic candidates.
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Operational Success By Strategic Investment
Explore how infrastructure, equipment strategy, and advanced technologies shape a more reliable path for scaling sterile injectable programs.
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- When Unexpected Particles Threaten Your Biologic
- Life Cycle Assessment (LCA): Empowering Sustainable Decisions
- Controlling Nitrosamine Risk In Drug Products: Detection, Formation, And Control Strategies
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- When High-Stakes ADC Decisions Can't Wait for More Material or Better Data